Contact lens packages

ABSTRACT

A package having a roughened surface that does not adhere to a medical device enclosed therein.

RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 10/183,133, filed on Jul. 26, 2002, now pending.

This invention related to packages for storing contact lenses as well asmethods of using and preparing these packages.

BACKGROUND

Contact lenses have been used commercially to improve vision since the1950s. At first contact lenses were made of hard materials, which wererelatively easy to handle and package for use, but were uncomfortablefor many patients. Later developments, gave rise to softer morecomfortable lenses made of hydrophobic hydrogels, particularly siliconehydrogels. These lenses are very pliable, but due to this texture andtheir chemical composition, they present a number of problems withpackaging.

Most contact lenses are packaged in individual blister packages having abowl portion and a foil top, where the bowl portion is made from ahydrophobic material such as polypropylene. See U.S. Pat. Nos.4,691,820; 5,054,610; 5,337,888; 5,375,698; 5,409,104; 5,467,868;5,515,964; 5,609,246; 5,695,049; 5,697,495; 5,704,468; 5,711,416;5,722,536; 5,573,108; 5,823,327; 5,704,468; 5,983,608; 6,029,808;6,044,966; and 6,401,915 for examples of such packaging, all of whichare hereby incorporated by reference in their entirety. Whilepolypropylene is resilient enough to withstand the sterilization stepsof contact lens manufacture, this material has an affinity for contactlenses made of silicone hydrogels. When silicone hydrogels are packagedin polypropylene bowls, the lenses stick to the bowl and cannot beremoved from the package without damaging the pliable lenses. Thereforeis a need to prepare a contact lens package that has resilientproperties, but does not stick to the final product. It is this needthat is met by the following invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates the top plan view of a contact lens package.

FIG. 2 illustrates the side plan view of a contact lens package

FIG. 3 illustrates the top plan view the maze configuration.

FIG. 4 illustrates the top plan view of radial configuration.

FIG. 5 illustrates the top plan the cross hair design configuration.

FIG. 6 a illustrates the top plan view of the logo configuration.

FIG. 6 illustrates the bottom plan view of the logo configuration.

FIG. 7 illustrates the top plan view of the spin wheel configuration.

FIG. 8 illustrates the top plan view of the ferris wheel configuration.

FIG. 9 illustrates the top plan view of the golf ball configuration.

FIG. 10 illustrates the top plan view of the sand dollar configuration.

FIG. 11, illustrated the top plan view of an enlarged portion of innersurface of the maze configuration.

DETAILED DESCRIPTION OF THE INVENTION

This invention includes a package for storing medical devices in asolution comprising, consisting essentially of, or consisting of,

-   (a) a molded base comprising    -   a cavity formed in said molded base wherein said cavity        comprises an inner surface, and    -   a flange extending outwardly from the periphery of said cavity        wherein said flange comprises a top surface;-   (b) a flexible cover sheet superimposed over said top surface of    said flange and detachably sealed to said flange at about the    periphery of said cavity to form an enclosure between said inner    surface and said flexible cover,    -   wherein said inner surface has sufficient roughness so that a        medical device contained within said enclosure floats freely in        a solution.

Further, the invention includes a method of reducing the adherence of amedical device to its package comprising, consisting essentially of, orconsisting of, storing said medical device in a solution in a packagecomprising, consisting essentially of, or consisting of,

-   (a) a molded base comprising    -   a cavity formed in said molded base wherein said cavity        comprises an inner surface, and    -   a flange extending outwardly from the periphery of said cavity        wherein said flange comprises a top surface;-   (b) a flexible cover sheet superimposed over said top surface of    said flange and detachably sealed to said flange at about the    periphery of said cavity to form an enclosure between said inner    surface and said flexible cover,    -   wherein said inner surface has sufficient roughness so that a        medical device contained within said enclosure floats freely in        a solution.

Still further, the invention includes a package for storing medicaldevices in a solution comprising, consisting essentially of, orconsisting of,

-   (a) a molded base comprising    -   a cavity formed in said molded base wherein said cavity        comprises an inner surface, and    -   a flange extending outwardly from the periphery of said cavity        wherein said flange comprises a top surface;-   (b) a flexible cover sheet superimposed over said top surface of    said flange and detachably sealed to said flange at about the    periphery of said cavity to form an enclosure between said inner    surface and said flexible cover,    -   wherein the surface contact area of said inner surface is about        25 percent to about 75 percents of said inner surface.

Yet, still further, the invention includes a package for storing medicaldevices in a solution comprising, consisting essentially of, orconsisting of,

-   (a) a molded base comprising    -   a cavity formed in said molded base wherein said cavity        comprises an inner surface, and    -   a flange extending outwardly from the periphery of said cavity        wherein said flange comprises a top surface;-   (b) a flexible cover sheet superimposed over said top surface of    said flange and detachably sealed to said flange at about the    periphery of said cavity to form an enclosure between said inner    surface and said flexible cover,    -   wherein the surface contact area of said inner surface is about        25 percent to about 75 percents of said inner surface, and a        medical device contained within said enclosure floats freely in        a solution.

Even, yet still further, the invention includes a method of making amolded base comprising

-   -   a cavity formed in said molded base, wherein said cavity        comprises an inner surface, and    -   a flange extending outwardly from the periphery of said cavity        wherein said flange comprises a top surface;    -   wherein said inner surface of said cavity has sufficient        roughness so that a medical device contained within said cavity        floats freely in a solution        wherein the method comprises, consists essentially of, or        consists of roughening the mold forming surface of a tool to a        sufficient roughness and forming the mold on said surface of a        tool.

As used herein a “medical device” is any device that is used to treat ahuman condition and is packaged in a solution. Examples of medicaldevices include but are not limited to ophthalmic devices that reside inor on the eye. Ophthalmic devices includes but are not limited to softcontact lenses, intraocular lenses, overlay lenses, ocular inserts, andoptical inserts. These devices can provide optical correction or may becosmetic. The preferred medical devices of the invention are softcontact lenses made from silicone elastomers or hydrogels, which includebut are not limited to silicone hydrogels, and fluorohydrogels. Softcontact lens formulations are disclosed in U.S. Pat. No. 5,710,302, WO9421698, EP 406161, JP 2000016905, U.S. Pat. No. 5,998,498, U.S. patentapplication Ser. No. 09/532,943, U.S. Pat. No. 6,087,415, U.S. Pat. No.5,760,100, U.S. Pat. No. 5,776,999, U.S. Pat. No. 5,789,461, U.S. Pat.No. 5,849,811, and U.S. Pat. No. 5,965,631. The foregoing references arehereby incorporated by reference in their entirety. The particularlypreferred medical devices of the invention are soft contact lenses madefrom etafilcon A, genfilcon A, lenefilcon A, polymacon, acquafilcon A,balafilcon A, lotrafilcon A. and silicone hydrogels as prepared in U.S.Pat. No. 5,998,498, U.S. patent application Ser. No. 09/532,943, acontinuation-in-part of U.S. patent application Ser. No. 09/532,943,filed on Aug. 30, 2000, U.S. Pat. No. 6,087,415, U.S. Pat. No.5,760,100, U.S. Pat. No. 5,776,999, U.S. Pat. No. 5,789,461, U.S. Pat.No. 5,849,811, and U.S. Pat. No. 5,965,631. These patents as well as allother patent disclosed in this application are hereby incorporated byreference in their entirety. The most particularly preferred medicaldevices of the invention are soft contact lenses made acquafilcon A,balafilcon A, or lotrafilcon A.

The term “solution” refers to any liquid medium in which a medicaldevice is stored. The preferred solutions are aqueous solutions containphysiological buffers. The particularly preferred solution is salinesolution. The term “cavity” refers to an unfilled space suitable forholding a medical device and a solution. If the medical device is a softcontact lens shape of the cavity can be, but is not limited to the shapeof the cavities in U.S. Pat. Nos. 4,691,820; 5,054,610; 5,337,888;5,375,698; 5,409,104; 5,467,868; 5,515,964; 5,609,246; 5,695,049;5,697,495; 5,704,468; 5,711,416; 5,722,536; 5,573,108; 5,823,327;5,704,468; 5,983,608; 6,029,808; 6,044,966; and 6,401,915. The term“inner surface” refers to the surface of the cavity that is adjacent,but not adhering to the medical device.

The term “floats freely” refers to the physical interaction of themedical device with the molded base and the solution. A medical devicefloats freely in solution when the molded base filled with the deviceand the solution is rotated or jiggled in a manner where the solution isnot spilled and the medical device contained therein, does not adhere tothe inner surface of said molded base. For example if the medical deviceis a contact lens packaged with saline solution, the physicalinteraction of the contact lens with its packaging may be tested asfollows. The flexible cover sheet is removed and the molded base isrotated or jiggled without spilling the saline solution while thecontact lens is observed to determine if it is adhered to the innersurface of the molded base.

The term “sufficient roughness” refers to the texture of the innersurface. Functionally, this surface must be rough enough so that amedical device immersed in a solution floats freely in said solution.For example, if the medical device is a contact lens immersed in apacking solution, particularly a silicone hydrogel contact lens, saidlens floats freely in the packing solution.

The degree of roughness can be expressed as the average roughness (“Ra,”μm) which is measured by a number of machines which include but are notlimited to Dimension 3000, manufactured by Digital Instruments, New View200, manufactured by Zygo Corporation, and Form Talysurf Series Two,manufactured by Taylor Hobson Precision. The choice of machine isdetermined by the roughness of the surface. For example for surfaceshaving a surface roughness of ≦1.00 μm the Dimension 3000 may be used.For rougher surfaces, either the New View 200 or the Form TalysurfSeries Two, may be used. Preferably, the Ra of the inner surface isabout 0.2 μm to about 20. μm, more preferably, about 1.8 μm to about 4.5μm, even more preferably about 1.9 μm to about 2.1 μm, more preferablystill about 0.3 μm to about 0.9 μm, even more preferably about 0.4 μm toabout 0.9 μm, even more still, about 0.5 μm to about 0.8 μm, and mostpreferably about 0.6 μm.

The molded base may be prepared from any number of materials providedthat those materials are compatible with the inspection andsterilization requirements of device manufacture. Examples of suitablematerials include but are not limited to polypropylene, polyethylene,nylons, olefin co-polymers, acrylics, rubbers, urethanes,polycarbonates, or fluorocarbons. The preferred materials aremetallocenes polymers and co-polymers made of polypropylene,polyethylene, having a melt flow range of about 15 g/10 minutes to about44 g/10 minutes as determined by ASTM D-1238. The molded base is formedby any of a number of methods, which include but are not limited toinjection molding, where the surface of the metal tool that is used toform the molded base is roughened by glass bead blasting or electrondischarge machining (“EDM”) to serve as a template for the roughenedinner surface.

The “flexible cover sheet” can be an adhesive laminate of an aluminumfoil and a polypropylene film or any other extruded or co-extruded filmthat can be sealed to the top surface of the flange in order to form ahermetic seal for the medical device and the solution. The flexiblecover need not be completely sealed to the entire top surface of theflange and preferably the flexible cover sheet is sealed an area of theflange that is in close proximity to the cavity. Further the flexiblecover sheet need not cover the entire top surface of said molded base.As used herein, the term “forming refers to all suitable methods ofpreparing of preparing the molded base, including but not limited toinjection molding and thermal molding. The preferred method of formingthe molded base is injection molding.

As used herein the term “surface contact area” refers to the portion ofthe inner surface that can have physical contact with, but does notadhere to the medical device. Due to fact that the medical device floatsfreely in the packaging, the inner surface may have areas that are notin contact with the medical device at all times, particularly when thepackage is rotated. Therefore, the surface contact area is measured as apercentage of total inner surface that can have contact with the medicaldevice, at any time. The preferred surface contact area is about 33 toabout 65 percent of the inner surface.

FIG. 1 illustrates the top plan view of one embodiment of the invention,a contact lens package. Molded base 10, having a rectangular flange 22,having a top surface 20 and inner surface 13, is shown. The flexibleclover sheet 40 (not shown) is detachably attached to top surface 20 atthe raised annular sealing area 14. FIG. 2 illustrates the side planview the package having cavity 30, flexible cover sheet 40 (shown halfpulled back), the packaged contact lens, 17 and solution 18.

Inner surface 13 may be roughed with glass bead blasting, EDM or othertreatments. For example in order to produce an inner surface having anRa of about 1.0 μm to about 2.0 μm, the tools that are used to form themolds are glass bead blasted on the appropriate surface. For example inorder to produce an inner surface having an Ra of about 1.0 μM, the toolis blasted at a pressure of about 40 to about 60 psi for about 20 secs.To produce an inner surface having an Ra of about 2.0 μm, the tool isblasted at a pressure of about 60 to about 80 psi for about 20 secs. Inorder to produce inner surfaces having an Ra 19 μm, a design is etchedon the appropriate surface of the tool using EDM and the same surface istreated glass bead blasted at about 40 to about 60 psi.

In order to produce an inner surface having an surface contact area ofabout 30 percent to about 70 percent, a design is formed on the tool'sappropriate surface using EDM. A number of different designs for innersurface 13 are illustrated in the following figures. FIG. 3 illustratesthe top plan view of inner surface 13, in the maze configuration. FIG. 4illustrates the top plan view of inner surface 13, in the radialconfiguration. FIG. 5 illustrates the top plan view of inner surface 13,in the cross hair design configuration. FIG. 6 illustrates the bottomplan view of inner surface 13, in the logo configuration. FIG. 6 aillustrates the top plan view of inner surface 13, in the logoconfiguration. FIG. 7 illustrates the top plan view of inner surface 13,in the spin wheel configuration. FIG. 8 illustrates the top plan view ofinner surface 13, in the ferris wheel configuration. FIG. 9 illustratesthe top plan view of inner surface 13, in the golf ball configuration.FIG. 10 illustrates the top plan view of inner surface 13, in the sanddollar configuration. FIG. 11, illustrated the top plan view of anenlarged portion of inner surface 13 of the maze configuration. In thisfigure representative raised portions 41 and recessed portions 43 areillustrated. The surface contact area of inner surfaces 13 surfaces maybe calculated by the measuring the surface area of all raised portionsand recessed portions of the inner surface.

When soft contact lenses are prepared the lenses cured to a hard discand subsequently hydrated with water to give the non-sterilized finalproduct. During this hydration step, soft contact lenses often stick tothe surface of the hydration chamber and it would useful to find amethod of hydrating soft contact lenses which alleviates this problem.

To solve this problem, the invention includes a method of hydrating acontact lens comprising, consisting essentially of, or consisting ofhydrating said lens in a molded base wherein said molded base comprisesa cavity formed in said molded base, wherein said cavity comprises aninner surface wherein said inner surface of said cavity has sufficientroughness so that a contact lens contained within said cavity floatsfreely in a solution.

Further, the invention includes a method of hydrating a contact lenscomprising, consisting essentially of, or consisting of hydrating saidlens in a molded base wherein said molded base comprises a cavity formedin said molded base, wherein said cavity comprises an inner surfacewherein the surface contact area of said inner surface is about 25percent to about 70 percents of said inner surface.

Still further, the invention includes a molded base comprising,consisting essentially of, or consisting of a cavity formed in saidmolded base, wherein said cavity comprises an inner surface wherein saidinner surface has sufficient roughness so that a medical devicecontained within said cavity floats freely in a solution.

Yet still further, the invention includes a molded base comprising,consisting essentially of, or consisting of, a cavity formed in saidmolded base wherein said cavity comprises an inner surface wherein thesurface contact area of said inner surface is about 25 percent to about75 percents of said inner surface.

Even yet still further, the invention includes a method of making amolded base comprising a cavity formed in said molded base, wherein saidcavity comprises an inner surface wherein said inner surface hassufficient roughness so that a medical device contained within saidcavity floats freely in a solution.

wherein the method comprises, consists essentially of, or consists ofroughening the inner surface. As used herein, the term “roughening”refers to methods of changing the texture of the inner surface whichinclude but are not limited to glass bead blasting or EDM treatment.

In order to illustrate the invention the following examples areincluded. These examples do not limit the invention. They are meant onlyto suggest a method of practicing the invention. Those knowledgeable incontact lenses as well as other specialties may find other methods ofpracticing the invention. However, those methods are deemed to be withinthe scope of this invention.

EXAMPLES Example 1 Preparation of Packages with Different Inner Surfaces

Nickel plated polished inserts were held in a rotating fixture. Thefixture was rotated for a duration of 20 seconds at one revolution persecond and sprayed from an angle of 30 degrees at a distance of 89 mmwith glass beads (Cyclone Glass Bead, 60-100 G, R3893 medium) from aCyclone 6.500 mm (diameter) nozzle. To produce a light blast thepressure of the spray is set at 40 psi. To produce a medium blast, thepressure is set at 60 psi. To produce a heavy blast, the pressure is setat 80 psi. These inserts were used to injection mold the base of severaldifferent contact lens packages from polypropylene (Exxon Achieve,PP1605, a metallocene polypropylene having a melt flow of 32 g/10minutes, ASTM D-1238 (L). If the required degree of roughness was notobtained after one roughening procedure, the inserts were roughenedagain.

Example 2 Preparation of Several Designs

Polished nickel plated inserts were held in a fixture. The desireddesigns were produced using a CAD software system and exported to acomputer system of a laser cutting machine. The insert was attached to afixture of the laser cutting machine and the inserts were cut using thatmachine. After EDM treatment some inserts were glass bead blasted aswell. These inserts were used to injection mold the base of severaldifferent contact lens packages from polypropylene (Exxon Achieve,PP1605, a metallocene polypropylene having a melt flow of 32 g/10minutes, ASTM D-1238 (L).

Example 3 Testing of Contact Lens Packages

Contact lenses made from acquafilcon A, a silicone hydrogel, were addedto individual polypropylene blister packs having different innersurfaces containing 950 μL of saline solution and then the blister packwas heat sealed. Lenses were visually evaluated for lens' adhesion tothe package after sterilization. The design of the package, the Ranumber (μm), percentage of surface contact area, the number of lensesthat stuck to the package, and number of lenses that were free floatingis displayed in Table 1. TABLE 1 percent surface Inner Surface Ra, μmcontact area # lenses tested # stuck control 0.139 100 84 84 light blast0.549 N/A 12 4 medium blast 1.038 N/A 60 2 heavy blast 1.912 N/A 60 0maze N/A 65 60 0 cross hair N/A N/A 12 8 spin wheel N/A N/A 12 8 ferriswheel N/A 2 12 12 sand dollar N/A 11 12 11 golf ball N/A 16 12 9 logodesign N/A N/A 12 12 radial design N/A 33 60 1 maze with 19.1 N/A 60 0medium blast cross hair with N/A N/A 60 0 medium blast ferris wheel withN/A N/A 80 0 medium blast logo with N/A N/A 60 2 medium blastThis table illustrates the ability of a roughened inner surface toprevent adherence of the lens to its package. The term “N/A” means notavailable.

1. A package for storing medical devices in a solution comprising (a) amolded base comprising a cavity formed in said molded base wherein saidcavity comprises an inner surface, and a flange extending outwardly fromthe periphery of said cavity wherein said flange comprises a topsurface; (b) a flexible cover sheet superimposed over said top surfaceof said flange and detachably sealed to said flange at about theperiphery of said cavity to form an enclosure between said inner surfaceand said flexible cover, wherein said inner surface has sufficientroughness so that a medical device contained within said enclosurefloats freely in a solution.
 2. The package of claim 1 wherein thedevice is a contact lens.
 3. The package of claim 2 wherein the contactlens is selected from the groups consisting of etafilcon A, genfilcon A,lenefilcon A, polymacon, acquafilcon A, balafilcon A, and lotrafilcon A4. The package of claim 2 wherein the contact lens is acquafilcon A,balafilcon A, or lotrafilcon A.
 5. The package of claim 1 wherein theinner surface has an average roughness of about 4 μm to about 0.6 μm.6-8. (canceled)
 9. The package of claim 1 wherein the inner surface hasan average roughness of about 0.5 μm. 10-23. (canceled)